The main objective of this core is the enrollment of every patient AML and MDS referred to Washington University into the Tissue Acquisition and Clinical Database protocol of the GAML program project. Skin, oral mucosa, bone marrow, peripheral blood leukocytes and serum specimens collected from patients will be banked and processed by Core B, (Specimen Database), whereupon they will serve as the basis for genomic analyses outlined in Core C (Sequencing and Analysis), to be utilized in Projects 1-4. This Clinical Core will also maintain and expand a comprehensive database that captures essential clinical, pathological, karyotypic, molecular, therapeutic, and outcomes data of enrolled AML and MDS patients, anonymously linked with the corresponding tissue specimens. The Clinical Core database will provide key clinical annotation for the samples prepared by Core B, and genomic studies performed by Core C, which will be utilized by Projects 1-4.
Specific Aim /Core Service 1: We will attempt to prospectively enroll and collect tissue at diagnosis, in remission, and at relapse from every patient referred to the Washington University Siteman Cancer Center with AML and MDS.
Specific Aim /Core Service 2: We will maintain a comprehensive clinical leukemia database that will capture epidemiological data, disease- related characteristics, prognostic factors, therapeutic information, and outcomes data from all enrolled AML and MDS patients, with de-identified linkage to corresponding banked tissue specimens.
Specific Aim /Core Service 3: We will provide statistical and informatics support for all PPG activities, including sample size assessments for human and mouse studies, detailed statistical evaluations of all datasets for publications, and IT support for database management.
The use of Next Generation DNA sequencing approaches for applications such as the discovery of disease- specific mutations in cancer, the study of clonal evolution over time, and for determination of minimal residual disease, are dependent upon the ready availability of large numbers of high quality specimens of both tumor and normal tissue, with accompanying clinical annotation. The Clinical Database Core (Core A) has systematically collected serial specimens from 793 MDS patients and 1528 AML patients since 2001, and has served as cornerstone for the genomic studies conducted by the GAML PPG, leading to dozens of high profile publications over the past 15 years.
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